FDA-approved drugs are provided in many different forms based on the type of active substance, the indication treated and the preferred route of administration. These forms include enteral formulations (e.g., tablets, capsules or pills), parenteral formulations (e.g., injectable formulations such as intravenous, subcutaneous, intramuscular and intraarticular), liquid formulations (e.g., elixirs), lyophilized formulations and topical formulations. A majority of the FDA-approved drugs are currently available in enteral form, as either a tablet or capsule.
The production of pharmaceutical drugs in pill form by hot melt extrusion is relatively uncommon. While the idea of dissolving drugs in polymers and using extrusion to produce a pill has been known for decades, only a handful of FDA-approved drugs are extruded. Recently, extrusion techniques have been investigated for preparing abuse deterrent formulations. For example, U.S. Pat. No. 8,075,872 (assigned to Grunenthal GmbH) is directed to a thermoshaped abuse deterrent dosage form prepared with the assistance of an extruder. The extrudate may be shaped by the assistance of contra-rotating calendar rolls, and singulated by conventional means such as chopping. U.S. Pat. No. 8,383,152 (assigned to Grunenthal GmbH) is directed to a controlled release pharmaceutical dosage form that may also be prepared by extrusion and shaped by a calendaring process. U.S. 2007/0190142 (assigned to Abbott GmbH) is directed to a sustained release abuse deterrent dosage form prepared by extrusion and shaping the extrudate into a dosage form without a milling or multi-particulating step.